本文選題：HIV + ART　； 參考：《中國疾病預(yù)防控制中心》2017年碩士論文

【摘要】：目的:本研究通過開展兩個橫斷面調(diào)查,分別觀察:1、部分地區(qū)接受艾滋病抗病毒治療12個月左右患者的HIV (Human Immunodeficiency Virus)耐藥情況及其影響因素;2、部分地區(qū)中止抗病毒治療患者HIV耐藥情況及其影響因素。方法:1、本研究的調(diào)查方案按照全國艾滋病病毒耐藥性監(jiān)測指南(2012版)中獲得性HIV耐藥橫斷面研究方案進(jìn)行。在北京、吉林、湖南、廣西、四川、貴州、新疆和云南8個監(jiān)測地區(qū)開展相關(guān)調(diào)查。本研究的目標(biāo)人群納入標(biāo)準(zhǔn)為:(1)HIV陽性患者;(2)年齡≥18歲;(3)接受免費(fèi)艾滋病抗病毒治療(Antiretroviral Therapy, ART) 9-18個月;(4)自愿參加調(diào)查并愿意提供知情同意書。2、在四川、重慶、云南、廣西、河南和湖南6個地區(qū),對上述省中止抗病毒治療的部分患者展開相關(guān)調(diào)查。本研究的目標(biāo)人群納入標(biāo)準(zhǔn)為:(1) HIV陽性患者;(2)年齡≥18歲;(3)中止治療1個月及以上;(4)自愿參加調(diào)查并愿意提供知情同意書。結(jié)果:1、2014年在8個地區(qū)共調(diào)查了 765名接受9-18個月抗病毒治療的成人,平均年齡是44.7歲。男性546 (71.4%)人,女性219 (28.6%)人;漢族607 (79.3%)人,少數(shù)民族158 (20.7%)人;已婚325 (42.5%)人,未婚440 (57.5%)人;67.6%的患者通過異性途徑感染艾滋病病毒。多數(shù)病人(56.0%)初始治療方案使用的是AZT/3TC/EFV或NVP,其次就是TDF/3TC/EFV或NVP (29.9%),二線方案使用者有50 (6.5%)人。經(jīng)過13.9個月的中位治療時間后,CD4細(xì)胞計(jì)數(shù)≥350組的患者比例從抗病毒治療前的17.2%提高到調(diào)查時的37.4%,同時CD4細(xì)胞計(jì)數(shù)中位數(shù)從抗病毒治療開始前的222cells/ul升高到調(diào)查時的303cells/ul。765位接受調(diào)查的患者中,65 (8.5%)位患者在調(diào)查時病毒載量抑制失敗(病毒載量≥1000 copies/ml)。對這65位病毒抑制失敗患者進(jìn)行擴(kuò)增,64位患者成功得到合格的pol基因序列,有33位患者出現(xiàn)耐藥突變位點(diǎn),耐藥率為4.3%。33位耐藥患者中,所有人都出現(xiàn)了對 NNRTIs (non-nucleoside reverse transcriptase inhibitors)藥物的耐藥,81.8%的患者對 NRTIs (nucleoside reverse transcriptase inhibitors)藥物耐藥,而 3%的患者出現(xiàn)了對 PIs(protease inhibitors)藥物的耐藥。NNRTIs最常出現(xiàn)的耐藥突變位點(diǎn)是K103N(54.5%,18/33),G190A/S/R/(27.3%,9/33),和 Y181C (24.2%,8/33); NRTIs 最常出現(xiàn)的是位于 RT 區(qū)的M184I/V (66.7%,22/33)和 K65R (39.4%,13/33),而 Pis 突變位點(diǎn)僅在 M46L 這個位點(diǎn)出現(xiàn)。多因素統(tǒng)計(jì)中發(fā)現(xiàn)兩個變量與耐藥發(fā)生有關(guān):過去一個月服藥比例在90%以下的患者發(fā)生耐藥的風(fēng)險是服藥比例在90%以上的患者的6倍(95%CI:1.7-20.7;P=0.005);四川和貴州的患者發(fā)生耐藥的風(fēng)險是其他省份的7.3倍(95%CI:3.6-15.2;P0.0001)。2、本次共調(diào)查了 481位中止抗病毒治療患者,所有的患者均采集全血樣本并進(jìn)行實(shí)驗(yàn)室檢測,其中365人接受問卷調(diào)查。對接受問卷調(diào)查的365人分析顯示,男性258 (70.7%)人,女性107 (29.3%)人;漢族222 (60.8%)人,其他民族143 (39.2%)人;農(nóng)村戶口291 (79.7%)人,城鎮(zhèn)戶口 74(20.3%)人;221 (60.5%)人感染途徑為異性傳播,17(4.7%)人為同性傳播,100 (27.4%)人通過吸毒傳播,27 (7.4%)人通過其他途徑傳播。中止治療 1-6 個月患者有 86 (23.6%)人,6-12 個月 75 (20.6%)人,12-24 個月 85 (23.3%)人,24-36個月36 (9.7%)人,≥36個月42 (11.5%)人。在所調(diào)查對象中,52人(10.8%)因治療失敗中止治療,124人(25.8%)因副反應(yīng)中止治療,177人(36.8%)因依從性問題中止治療。481位采集到樣本的中止治療患者中,337 (70.1%)位患者在調(diào)查時病毒載量≥1000 copies/ml。對這337位患者進(jìn)行基因擴(kuò)增,336 (99.7%,336/337)位患者成功得到序列,其中有65位患者至少攜帶一個耐藥突變,耐藥率為13.5%。65位耐藥患者中,57 (87.7%,57/65)例患者出現(xiàn)了對NNRTIs藥物的耐藥,4.6% (3,3/65)的患者對NRTIs藥物耐藥,而10.8% (7,7/65)的患者出現(xiàn)了對Pis藥物的耐藥。NNRTIs最常出現(xiàn)的耐藥突變位點(diǎn)是K103N(56.9%,37/65); NRTIs 最常出現(xiàn)的是位于 RT 區(qū)的 M184I/V (3.1%, 2/65),而 Pis 突變位點(diǎn)僅在I54V這個位點(diǎn)出現(xiàn)。多因素統(tǒng)計(jì)中發(fā)現(xiàn)兩個變量與耐藥發(fā)生有關(guān):沒有醫(yī)療保險的中止治療患者發(fā)生耐藥的風(fēng)險是有醫(yī)療保險患者的2.8倍(95%CI:1.2-6.6;P=0.02);調(diào)查時CD4細(xì)胞計(jì)數(shù)0-199 copies/ml的中止治療患者發(fā)生耐藥的風(fēng)險是CD4細(xì)胞計(jì)數(shù)≥350 copies/ml的患者的3.6倍(95%CI:1.4-8.9;P=0.006),調(diào)查時CD4細(xì)胞計(jì)數(shù)200-350 copies/ml的患者發(fā)生耐藥的風(fēng)險是CD4細(xì)胞計(jì)數(shù)≥350 copies/ml的患者的3.5倍(95%CI:1.4-8.4;P=0.006)。多因素統(tǒng)計(jì)中發(fā)現(xiàn)兩個變量與病毒未抑制有關(guān):病人在抗病毒治療時從縣或市醫(yī)院領(lǐng)取藥物發(fā)生病毒未抑制(病毒載量≥1000 copies/ml)的風(fēng)險是患者從村、鎮(zhèn)衛(wèi)生院領(lǐng)藥的2.9倍(95%CI:1.6-5.3;P=0.0003);調(diào)查時CD4細(xì)胞計(jì)數(shù)0-199 copies/ml的患者發(fā)生病毒載量未抑制的風(fēng)險是 CD4 細(xì)胞計(jì)數(shù)≥350 copies/ml 的患者的 10.3 倍(95%CI:4.9-21.7;P0.0001),調(diào)查時CD4細(xì)胞計(jì)數(shù)200-350 copies/ml的中止治療患者發(fā)生病毒載量未抑制的風(fēng)險是CD4細(xì)胞計(jì)數(shù)≥350 copies/ml的患者的 4.6 倍(95%CI:2.6-8.3;P0.0001)。結(jié)論:綜上所述,本研究表明現(xiàn)階段一直持續(xù)服用免費(fèi)抗病毒治療藥物9-18個月患者病毒抑制率已達(dá)到WHO提出的90%的病毒抑制標(biāo)準(zhǔn),治療后患者的CD4細(xì)胞計(jì)數(shù)值明顯升高,耐藥發(fā)生率為4.3%,但是四川和貴州耐藥發(fā)生較高。在中止抗病毒治療患者中病毒未抑制率和耐藥比例均較高,其中耐藥率達(dá)到13.5%,調(diào)查時CD4細(xì)胞計(jì)數(shù)低的患者發(fā)生耐藥和病毒未抑制的風(fēng)險大,患者中止抗病毒治療原因主要是藥物副反應(yīng)和依從性不好,應(yīng)針對患者退出的原因,制定相應(yīng)措施降低退出的比例,同時需進(jìn)一步加強(qiáng)中止治療人群的耐藥監(jiān)測。雖然堅(jiān)持服藥患者的耐藥流行較低,但本研究中發(fā)現(xiàn)仍有一定比例中止抗病毒治療的患者中并有較高的耐藥發(fā)生,如不盡早采取措施,這將成為保持我國長期抗病毒治療效果的一個重要的制約因素。
[Abstract]:Objective: in this study, two cross-sectional investigations were carried out to observe: 1, in some areas, the drug resistance of HIV (Human Immunodeficiency Virus) and its influencing factors for patients with AIDS antiviral therapy for about 12 months and so on; 2, HIV resistance of patients with antiviral treatment in some areas and its influencing factors. Methods: 1. The scheme was conducted in 8 monitoring areas in Beijing, Jilin, Hunan, Guangxi, Sichuan, Guizhou, Xinjiang and Yunnan in Beijing, Jilin, Hunan, Guangxi, Guizhou, Xinjiang and Yunnan, in accordance with the National AIDS drug resistance monitoring Guide (2012 Edition). The target population of this study was included (1) HIV positive patients; (2) age more than 18 years; (3) accepted free of charge AIDS antiviral treatment (Antiretroviral Therapy, ART) 9-18 months; (4) voluntary participation in the survey and willing to provide the informed consent.2, in Sichuan, Chongqing, Yunnan, Guangxi, Henan and Hunan, 6 areas of the above-mentioned provinces to suspend antiviral treatment are investigated. The target population of this study is: (1) HIV positive patients (2) age more than 18 years old; (3) suspension of treatment for 1 months and more; (4) voluntary participation in the investigation and willing to provide informed consent. Results: 765 adults with 9-18 months of antiviral treatment were investigated in 8 regions for 12014 years, the average age was 44.7 years, 546 (71.4%) men, female 219 (28.6%) people, Han people, minority nationalities. 0.7%) people; married 325 (42.5%), unmarried 440 (57.5%); 67.6% of the patients infected with HIV through heterosexual pathways. Most patients (56%) were treated with AZT/3TC/EFV or NVP, followed by TDF/3TC/EFV or NVP (29.9%), and the second line scheme made the use of 50 (6.5%) people. After a median of 13.9 months of treatment, CD4 cells The proportion of patients who counted more than 350 groups increased from 17.2% before antiviral therapy to 37.4% in the survey, while the median of CD4 cell counts increased from 222cells/ul before the beginning of antiviral therapy to the 303cells/ul.765 position in the survey, and 65 (8.5%) patients failed to suppress viral load (viral load > 1000 COP) during the investigation. Ies/ml). To amplify the 65 patients with the failure of the virus, 64 patients successfully got a qualified pol gene sequence, 33 patients had resistance mutation sites, the drug resistance rate was 4.3%.33 resistant, all of them were resistant to NNRTIs (non-nucleoside reverse transcriptase inhibitors), and 81.8% of the patients were to NRT. Is (nucleoside reverse transcriptase inhibitors) drug resistance, and 3% of patients with PIs (protease inhibitors) drug resistant.NNRTIs most often appear the most common resistance mutation loci are K103N (54.5%, 18/33), G190A/S/R/ (24.2%, 66.7%). And K65R (39.4%, 13/33), and Pis mutation site only at the M46L site. Multifactor statistics found that two variables were associated with drug resistance: the risk of drug resistance in patients with less than 90% over the past month was 6 times as much as 90% of patients (95% CI:1.7-20.7; P=0.005); patients in Sichuan and Guizhou occurred. The risk of resistance was 7.3 times (95%CI:3.6-15.2; P0.0001).2 in other provinces. The total of 481 cases of antiviral treatment were investigated. All the patients collected whole blood samples and carried out laboratory tests. 365 of them were investigated by questionnaire. 258 (70.7%) men, 107 (29.3%) women, and 107 (29.3%) men were analyzed. 222 (60.8%) people and 143 (39.2%) people of other nationalities; 291 (79.7%) in rural areas and 74 (20.3%) in urban areas; 221 (60.5%) is transmitted by the opposite sex, 17 (4.7%) is transmitted by the same sex, 100 (27.4%) people spread through drug use, and people are transmitted through other ways. (20.6%) people, 12-24 months 85 (23.3%), 24-36 months 36 (9.7%), and 36 months 42 (11.5%). Among the subjects, 52 (10.8%) were discontinued for treatment failure, 124 (25.8%) was discontinued for side effects, and the patient was discontinued for the discontinuation treatment of the.481 position. In the survey, the 337 patients were amplified by viral load more than 1000 copies/ml., and 336 (99.7%, 336/337) patients succeeded in getting the sequence, of which 65 patients carried at least one drug resistance mutation, and the resistance rate was 13.5%.65 resistant, 57 (87.7%, 57/65) patients were resistant to NNRTIs drugs and 4.6% (3,3/65) patients. Drug resistance to NRTIs, and 10.8% (7,7/65) patients appeared the most frequently occurring resistance mutation loci of drug resistant.NNRTIs to Pis drugs (56.9%, 37/65); NRTIs most frequently appeared in M184I/V (3.1%, 2/65) located in RT region, while Pis mutation site appeared only at the I54V this site. Two variables were found in multifactor statistics and drug-resistant hair. Life - related: the risk of drug resistance in patients without medical insurance is 2.8 times as high as those with medical insurance (95%CI:1.2-6.6; P=0.02); the risk of drug resistance in patients with CD4 cell counts of 0-199 copies/ml at the time of investigation is 3.6 times (95%CI:1.4-8.9; P=0.006) in patients with CD4 cell counts more than 350 copies/ml. The risk of drug resistance in a cell count of 200-350 copies/ml was 3.5 times (95%CI:1.4-8.4; P=0.006) of the CD4 cell count of more than 350 copies/ml. The multifactor statistics found that two variables were not associated with the virus inhibition: the patients received drugs from the county or the city hospital during antiviral treatment (viral load > 1000 copies/). The risk of ML) was 2.9 times (95%CI:1.6-5.3; P=0.0003) from the village and the Town Health Hospital; the risk of uninhibited viral load in the CD4 cell count of 0-199 copies/ml was 10.3 times (95%CI:4.9-21.7; P0.0001) of the patients with CD4 cell counts more than 350 copies/ml, and the suspension of the CD4 cell count 200-350 copies/ml in the investigation. The risk of uninhibited viral load in the treatment patients was 4.6 times (95%CI:2.6-8.3; P0.0001) in patients with CD4 cell counts more than 350 copies/ml. Conclusion: To sum up, this study showed that the rate of virus inhibition in patients who had been taking free antiviral therapy at the present stage for 9-18 months had reached 90% of the virus inhibition standard proposed by WHO. The CD4 cell count of the patients was significantly higher, the incidence of drug resistance was 4.3%, but the drug resistance in Sichuan and Guizhou was higher. The rate of uninhibited virus and the drug resistance were higher in the patients who stopped the antiviral treatment, and the drug resistance rate reached 13.5%. The risk of drug resistance and the uninhibited virus was high in the patients with low CD4 cell count. The main reason for antiviral treatment is the adverse drug reaction and poor compliance. We should formulate corresponding measures to reduce the proportion of withdrawal, and further strengthen the drug resistance monitoring of the discontinued people. Although the prevalence of drug resistance in patients taking medicine is low, it is found that there is still a certain proportion of the discontinuation of antiviral treatment in this study. There is a high level of resistance in patients who are treated. If not taken early, it will become an important constraint to maintain the long-term efficacy of antiviral therapy in China.
【學(xué)位授予單位】：中國疾病預(yù)防控制中心
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：R512.91

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